Safety Study of APD-791 With Aspirin and/or Clopidogrel

NCT02034292 | Terminated Phase 1 DMC

• 1 other identifier: ID-TG1C-1301
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• To assess the safety of APD791 when orally co-administered with Aspirin and Clopidogrel in healthy subjects

  Adverse reaction monitoring for subjective or objective symptoms Physical examination Vital signs 12-electrode ECG Laboratory tests

  safety review will be conducted at every end of dosing (about every 2 or 3 weeks)

Secondary Outcomes (2)

• Pharmacokinetic characteristic evaluation variable

  After last patient last visit. About 8month later since start of the study.

• Pharmacodynamic characteristic evaluation variable

  Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.

Study Arms (9)

10mg MD

EXPERIMENTAL

APD791 10mg Multiple dose and

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

20mg MD

EXPERIMENTAL

APD791 20mg Multiple dose

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

40mg MD

EXPERIMENTAL

APD791 40mg Multiple dose

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

60mg MD

EXPERIMENTAL

APD791 60mg Multiple dose

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

Placebo MD

PLACEBO COMPARATOR

Placebo for Multiple dose group

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

120mg SD

EXPERIMENTAL

APD791 120mg Single dose

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

240mg SD

EXPERIMENTAL

APD791 240mg Single dose

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

320mg SD

EXPERIMENTAL

APD791 320mg Single dose

Drug: Clopidogrel; Drug: Aspirin; Drug: APD791

Placebo SD

PLACEBO COMPARATOR

Placebo for Single dose

Drug: Clopidogrel; Drug: Aspirin; Drug: Placebo

Interventions

Clopidogrel DRUG

10mg MD; 120mg SD; 20mg MD; 240mg SD; 320mg SD; 40mg MD; 60mg MD; Placebo MD; Placebo SD

Aspirin DRUG

10mg MD; 120mg SD; 20mg MD; 240mg SD; 320mg SD; 40mg MD; 60mg MD; Placebo MD; Placebo SD

APD791 DRUG

10mg MD; 120mg SD; 20mg MD; 240mg SD; 320mg SD; 40mg MD; 60mg MD; Placebo MD

Placebo DRUG

Placebo SD

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a healthy adult between 20 and 45 years old at the time of visit for screening
• a person who is able to give written consent
• a person between 50 and 85 kg at the time of visit for screening
• a woman who is negative on a serum hCG test at the time of visit and the day before a trial, and who is not nursing
• a woman who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, or who had a contraceptive operation no later than 120 days before visit for screening, or who is menopausal
• a man who had a contraceptive operation no later than 120 days before visit for screening, or who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, and also agree not to donate sperm
• a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
• a person whose vital signs were in the normal range at the time of visit for screening, or who is medically determined not to be clinically significant by an investigator
• a person who voluntarily decides to participate in this clinical trial and gives written consent on strict clinical trial compliance
• a person whose blood can be collected during a study period with visit for monitoring

You may not qualify if:

• a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
• a person with the medical history of gastrointestinal diseases(e.g. Crohn's disease, ulcerative colitis, etc.) or surgery(excluding uncomplicated appendectomy or herniotomy) affecting the absorption of a clinical trial drug
• a person with the medical history of blood coagulation disorder or hemorrhagic diseases, or with clinically significant abnormal findings decided by a investigator on blood coagulation test at the time of screening
• a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
• a person with the medical history of epilepsy or convulsion
• a person with the medical history of internal organ transplant
• a person expected to be hard to complete a clinical trial because of surgery or medical procedures planned within a clinical trial period
• a person with the medical history of clinically significant new diseases within 30 days from the time of visit for screening according to investigator's decision
• a person with hypersensitivity reaction to a drug or gelatin, or the medical history of clinically significant hypersensitivity reaction
• a person with the history of drug abuse, or with a positive reaction to a drug possible to be abused on urine drug screening
• a person with the medical history of alcohol abuse within two years from the time of visit for screening
• a person who is a smoker, or with a positive reaction on a urine nicotine test conducted at the time of visit for screening
• a person who donated whole blood within 60 days or constituents of blood within 30 days, or received a blood transfusion within 30 days from the time of visit for screening
• a person taking other clinical trial drugs within 90 days from the time of visit for screening
• a person taking a prescription drug within 30 days, or a contraindicated drug or oriental medicine within 14 days from the time of visit for screening

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead
• Asan Medical Center: collaborator

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel; Aspirin; APD791

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 13, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 15, 2019

Record last verified: 2019-02